HDR X-ray Source 2.2 S7601

GUDID 00858012005298

Axxent HDR X-Ray Source 25 cm ESL

Icad, Inc.

Intraoperative/postoperative therapeutic x-ray system x-ray source

• Primary Device ID: 00858012005298
• NIH Device Record Key: 109091bb-c5e5-4c2d-87f9-81aed8ecff11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HDR X-ray Source 2.2
• Version Model Number: 720684-02
• Catalog Number: S7601
• Company DUNS: 108870254
• Company Name: Icad, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858012005298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122951

FDA Product Code

• JAD: System, Therapeutic, X-Ray

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [HDR X-ray Source 2.2]

• 00858012005304: Axxent HDR X-Ray Source 50 cm HUT
• 00858012005298: Axxent HDR X-Ray Source 25 cm ESL
• 00858012005281: Axxent HDR X-Ray Source 25 cm HUT